LAAO SWISS-APERO 1-Year Data | SCAI

Why is this study important?  

The SWISS-APERO trial showed that Amulet is not superior to Watchman for LAA patency (assessed by CCTA) at 45 days among patients undergoing percutaneous LAAC. Results did not change at 13 months follow-up.  

Should I change my practice because of these findings?  

Based on this study, current practice will continue without any changes using either Amulet or Watchman devices for percutaneous LAAC.  

What question was the study supposed to answer?  

The goal of the trial was to demonstrate the superiority of Amulet compared with Watchman FLX for patients undergoing left atrial appendage closure (LAAC). 

What did the study show?  

The SWISS-APERO trial randomized 220 patients in an open-label fashion to LAAC with either Amulet (N=111) or Watchman (n=110). LAA patency on CCTA at 45 days for Amulet vs. Watchman FLX, was: 67.6% vs. 70% (p = 0.71). 13-month outcomes for Amulet vs. Watchman FLX showed patent appendage rate: 53.6% vs. 48.8% (p = 0.54). 30.5% of patent appendages at 45 days were resolved by 13 months and 13.2% had new-onset patent appendages between 45 days and 13 months. The clinical significance of these findings is unclear and will need to be further ascertained in future studies. DRT rate was low and similar; 2.4% vs. 3.8% (p = 0.61). Similarly, there was no significant difference in the composite rate of cardiovascular death/stroke/systemic embolism: 9.5% vs. 10.2% (p = 0.83).  

How good was the approach/methodology? 

SWISS-APERO was a well-designed study that provided us with important data comparing the only 2 FDA-approved devices for percutaneous LAAC, and showed no significant differences between them.  

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